Senior Clinical Trial Associate
克里亚是一家生物制药公司，其使命是为全球数百万患者影响的疾病开发改变生命的基因疗法。我们利用我们的专有计算引擎，内部生产基础设施和集成设计平台来工程技术和治疗，具有转型潜力在大量未满足需求的疾病中进行广泛的治疗，重点放在代谢障碍，神经学和眼科上。我们很自豪被评为"三角商业杂志2024年生命科学"最佳私营公司，福布斯认可是2024年的美国最好的初创雇主之一，并荣获生物空间2025年最佳工作地点之一。角色概述高级临床试验助理支持在光监下的临床开发项目规划和协调。这一职责适用于发展临床试 nghiệm 流程知识和 GCP 要求的帮助，以协助协调研究活动，确保遵守协议。临床试验高级副会员在临床运作方面建立了先前的专业知识，并独立地参与分配研究任务。关键责任 · 在研究启动，进行和完成阶段支持和领导临床试题活动协调。·协助编制和审查包括知情同意表格，现场手册和调查材料在内的研究文件。·与 CRO,临床供应商和临床站点提供沟通和物流服务，由资深团队成员指导。·通过 CTMS 和项目管理工具来负责跟踪和报告研究里程碑，时间线以及现场绩效指标。· 支持临床试验注册和公布发布过程。·参与数据审查和 eCRF 相关活动。·协调生物样本跟踪和物流，包括采集样品，装备工具包和运输时间表。· 支持账单审查并协助供应商文件和合同追踪。· 参加跨职能研究团队会议并协助后续行动。· 将 ICH/GCP 知识应用到日常活动中；加强对高级工作人员的遵守问题。· 帮助制定和维护 SOP 和操作过程文档。· 如有需要提供经验较少的 CTA 指导。执行其他需要支持临床操作团队的职责。
查看英文原文
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”
Role Overview
The Senior Clinical Trial Associate supports the planning and coordination of clinical development projects under light supervision. This role applies developing knowledge of clinical trial processes and GCP requirements to support in the coordination of study activities, ensuring compliance with protocols. The Senior Clinical Trial Associate is building on prior expertise in clinical operations and contributes independently to assigned study tasks.
Key Responsibilities
- Support and lead the coordination of clinical trial activities across study start-up, conduct, and close-out phases.
- Assist with the preparation and review of study documents including informed consent forms, site manuals, and investigator materials.
- Drive communication and logistics with CROs, clinical vendors, and clinical sites under guidance of senior team members.
- Lead tracking and reporting of study milestones, timelines, and site performance metrics using CTMS and project management tools.
- Support clinical trial registration and disclosure posting processes.
- Participate in data review and eCRF-related activities.
- Coordinate biosample tracking and logistics including sample collection, kit preparation, and shipping schedules.
- Support invoice review and assist with vendor documentation and contract tracking.
- Participate in cross-functional study team meetings and assist with follow-up actions.
- Apply ICH/GCP knowledge to day-to-day activities; escalate compliance questions to senior staff.
- Assist with the development and maintenance of SOPs and operational process documentation.
- Provide guidance to lesser experienced CTAs as needed.
- Perform other duties as required to support the Clinical Operations Team.
Experience & Skills and Work Environment
Experience & Skills
- Bachelor's degree or related experience required.
- 3-5+ years of experience in clinical operations required.
- Previous Biotech experience highly preferred.
- Moderate to developing knowledge of ICH/Good Clinical Practices (GCP).
- Experience with EDC systems, CTMS, or IRT systems preferred.
- Ability to apply standard practices and procedures in analyzing study data and situations.
- Strong communication and organizational skills; proficiency in Microsoft Office suite.
- Excellent attention to detail and ability to work across multiple protocols
- Ability to work independently on defined tasks and develop stable working relationships across functional teams.
- Experience in gene therapy or ophthalmology is a plus but not required.
- Ability to manage multiple tasks and prioritize in a fast-paced environment.
- Eagerness to learn and develop professional expertise in clinical operations
Work Environment
- Primarily desk-based in an office or home office setting.
- May involve extended periods of sitting and computer use.
- Occasional travel may be required.
Life at Kriya
Discover True Collaborative TeamworkWe have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.
We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
Rewards & Benefits
- Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
- Health & Wellness: Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
- Financial Security:Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
- And More!
Originally posted on Himalayas